AAD: Restarting Anti-TNF Agent Works in Relapsed Psoriasis

Action Points

Explain to patients that relapsed psoriasis responded to retreatment with a biologic agent.

Note that the study involved only a small number of patients.

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

MIAMI BEACH -- A majority of patients with relapsed psoriasis regained control of the disease when retreated with the tumor necrosis factor (TNF) inhibitor adalimumab (Humira), results of a small clinical study showed.

Following retreatment, 26 of 32 patients had at least a 50% improvement in the psoriasis area and severity index (PASI 50). Half of the patients had PASI 75 responses.

"Response was regained by most patients who, following dosage reduction or interruption in therapy, were subsequently retreated with adalimumab weekly dosing," Mark Lebwohl, MD, of the Mount Sinai School of Medicine in New York City, and colleagues reported in a poster presentation at the American Academy of Dermatology meeting.

The findings came from a study designed to mimic "real-life" clinical practice. In certain circumstances, psoriasis patients might have a dosage reduction or treatment interruption. Among patients who subsequently relapsed, the safety and efficacy of retreatment with a TNF inhibitor had not been examined.

To assess retreatment, investigators enrolled patients who did not achieve at least a PASI 50 during the last 12 weeks of a 24-week randomized, placebo-controlled clinical trial.

All patients in the extension studyinitially received open-label adalimumab for 12 weeks. Patients who had a PASI ≥50 at that point then resumed treatment with their therapy from the randomized trial (adalimumab or placebo) for an additional 12 weeks.

Lebwohl and colleagues reported that all 32 patients who hadrelapsed during the double-blind study agreed to participate in the 24-week extension study. The extension population consisted of 21 patients from the placebo arm of the randomized study and 11 from the reduced doseadalimumab arm.

The patients in the extension study had a mean age of 48, almost two-thirds were men, mean weight was 96 kg (212 lbs), psoriasis duration averaged 19 years, body surface area affected averaged 26%, and PASI score averaged 16.

By physician's global assessment, half the patients had moderate psoriasis, 31% had moderate to severe, and 19% had severe disease.

After 12 weeks of open-label adalimumab, 81.3% of the patients had achieved a PASI 50.

Patients treated with adalimumab in the randomized extensionstudy had a higher response rate (10 of 11, 90.9%) compared with patients allocated to placebo (16 of 21, 76.2%). Additionally, PASI 75 responses occurred more often in patients initially randomized to adalimumab (eight of 11, 72.7%) versus placebo (six of 21, 38.1%).

Overall, 18 of 32 patients maintained at least a PASI 50 response through week 24 of the extension study.

Among patients who achieved PASI 50 responses at 12 weeks, relapse was more common during weeks 13 to 24 in patients who resumed placebo therapy (48.8% versus 37.5%). The difference was greatest at 21 weeks (43.8% versus 25%).

Two serious adverse events occurred in the adalimumab group. One patient discontinued during open-label therapy after developing a bleeding ulcer, and another patient withdrew after developing kidney stones, possibly from psoriasis-associated hyperuricemia.

Otherwise, the safety profile in retreated patients was consistent with the experience of adalimumab clinical trials, the investigators reported.